Immuno Exam 1 Study Guide
Advanced Immunotherapies from a Managed Care Perspec ve . Managed care perspec ve on specialty drugs o Managed care - Balance medical decisions w/ economic factors to achieve cost-e cient health outcomes : Apply busines prac ces to healthcare Goal: balance quality, access, and cost o Stakeholders Employer/client Providers Managed care organiza on Consumer/member Government/legal Drug manufacturers o Specialty meds :High complexity : High touch : High cost o Managed care pharmacy tools : Formulary & u liza on management : Pharmacy channel management : Clinical programs : Pipeline monitoring : Value-based pharmacy management Formulary management process o Components Formulary design . Open vs closed o Open: members have access to all meds on health plan formulary o Closed: o ers selec on of meds across therapeu c classes Tiering structure Newest greatest pony Designed by pharmacy & therapeu cs nisk ist munt or commi ees (P&T) evidena.most erp Spectalty Goal: encourage use of safe, e ec ve, a ordable meds Non-Preferred Maximizing generic u liza on Philosophy: generic drugs cost less for Prefevrad pts, insurers, & healthcare system Therapeu c drug equivalent o Generics are typically the et pota foi Generics formulary preference Jerstexpersne Therapeu c biosimilar equivalent U liza on management Prior auth o Usually seen for... Specialty meds for in ammatory condi ons, oncology, growth de ciency, hep c
Meds used commonly for o -label indica ons Meds w/ safety concerns Step therapy (ST) o Requires pa ent to have tried other preferred op ons before using higher er/non-preferred drug o Self-step Drug will be covered as long as pa ent is adherent Quanty limits (QLL) Limits qty of drug pt can receive over period ofme o Based on FDA-approved dosing & dura on of therapy & clinical guidelines
o Biologics & biosimilars Biologic product -- large, complex molecule used to diagnose, prevent, treat, & cure diseases & medical condi ons Produced through biotech in a living system :Reference product is FDA approved biologic product against which proposed biosimilars are compared Biosimilar product -- biologic product that is highly similar & has no clinically meaningful di erences from exis ng FDA approved reference product Interchangeable product - biosimilar w/ ability to produce same clinical response as reference product in any given pt : May be subs tuted for reference product w/o consul ng prescriber The Biologics Price Compeon and Innova on Act (BPCI Act) created an abbreviated approval pathway for biologics demonstra ng to be biosimilar to/interchangeable with and FDA approved biologic FDA purple book contains approved biologic products : Includes biosimilar & interchangeable products and their reference products
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Methods for op mizing health outcomes o Clinical programs : Quality performance CMS stars . Na onal Commi ee for Quality Assurance (NCQA) Pharmacy Quality Alliance (PQA) Design Iden fy areas of opportunity Develop clinical interven ons . Execute interven ons & evaluate impact on health outcomes O Who? : Teams of specialized pharmacists connect to care team to prov